| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| subjects with seasonal allergic rhinitis |
|
| MedDRA Classification |
| E.1.3 | Condition being studied is a rare disease | No |
| E.2 Objective of the trial |
| E.2.1 | Main objective of the trial |
| The aim of the study is to assess the efficacy of a combination therapy with Cetirizine and Pseudoephedrine under controlled pollen exposure in an Environmental Challenge Chamber and to assess if the efficacy is equivialent when assessed inside and outside the grass pollen season. |
|
| E.2.2 | Secondary objectives of the trial | |
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
• Male and female subjects, aged 18-55 years. Women will be considered for inclusion if they are:
Not pregnant, as confirmed by pregnancy test (see flow chart) and not nursing.
Of non-child bearing potential (i.e. physiologically incapable of becoming pregnant, including any female who is pre-menarchial or post-menopausal, with documented proof of hysterectomy or tubal ligation, or meet clinical criteria for menopause and has been amenorrhoeic for more than 1 year prior to the screening visit).
Of childbearing potential and using a highly effective method of contraception during the entire study (vasectomised partner, abstinence - the lifestyle of the female should be such that there is complete abstinence from intercourse from two weeks prior to the first dose of study medication until at least 72 hours after treatment -, implants, injectables, combined oral contraceptives, some IUDs)
• FEV1 > 80% of predicted at screening.
• Absence of any structural nasal abnormalities or nasal polyps on examination, absence of a history of frequent nose bleeding or recent nasal surgery.
• Absence of conditions or factors, which would make the subject unlikely to be able to stay in the Fraunhofer ECC for 6 hours.
• Non smokers or smokers with a history of less than 10 pack years.
• History of allergic rhinitis to grass pollen and a positive skin prick test for Dactylis glomerata pollen at or within 12 months prior to the screening visit.
• Subject must exhibit a moderate response upon 4000 Dactylis glomerata pollen grains/m3 during 2 hours in the ECC on visit 2, which is defined as a Nasal Obstruction Symptom Score (NOSS) of at least 2 (scored on a scale from 0 to 3) and a Total Nasal Symptom Score of at least 6 (TNSS is the sum of obstruction, rhinorrhea, itch, and sneeze, each of which has been scored on a scale from 0 to 3) at least once during the screening challenge.
• Subjects with mild stable asthma that is controlled with occasional use of as-needed short-acting beta-agonists and associated with normal lung function may be included.
• Able and willing to give written informed consent to take part in the study.
• Available to complete all study measurements.
|
|
| E.4 | Principal exclusion criteria |
• Subjects showing clinical symptoms of perennial allergic rhinitis.
• History of a respiratory tract infection and/or exacerbation of asthma within 4 weeks before the screening.
• Any history of life-threatening asthma, defined as an asthma episode that required intubation and/or was associated with hypercapnoea, respiratory arrest or hypoxic seizures.
• Administration of oral, injectable or dermal corticosteroids within 8 weeks or intranasal and/or inhaled corticosteroids 4 weeks prior to the screening visit.
• Past or present disease, which as judged by the investigator, may affect the outcome of this study. These diseases include, but are not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease, hematological disease, neurological disease, endocrine disease or pulmonary disease (including but not confined to chronic bronchitis, emphysema, tuberculosis, bronchiectasis or cystic fibrosis).
• Known hypersensitivity, allergic reactions or intolerance to cetirizine, pseudoephedrine or any of the other ingredients.
• Subject receiving monoamine oxidase inhibitors or has received these agents in the last two weeks before dosing.
• Specific Immunotherapy (SIT) within the last two years prior to screening.
• There is a risk of non-compliance with study procedures.
• Participation in another clinical trial 30 days prior to enrolment.
|
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
To assess the effect of a combination of cetirizine and pseudoephedrine on change of total nasal symptom score (TNSS), defined as the sum of obstruction, rhinorrhea, itch, and sneeze, each of which has been scored on a scale from 0 to 3, by spending 6 hours in an environmental challenge chamber with dosing after 2 hours, inside the grass pollen season.
To assess the effect of a combination of cetirizine and pseudoephedrine on change of total nasal Symptom score (TNSS), defined as the sum of obstruction, rhinorrhea, itch, and sneeze, each of which has been scored on a scale from 0 to 3, by spending 6 hours in an environmental challenge chamber with dosing after 2 hours, outside the grass pollen season.
To assess if the effect of a combination of cetirizine and pseudoephedrine on change of total nasal symptom score (TNSS) inside and outside the grass pollen season is equivalent.
|
|
| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | No |
| E.6.2 | Prophylaxis | No |
| E.6.3 | Therapy | Yes |
| E.6.4 | Safety | Yes |
| E.6.5 | Efficacy | Yes |
| E.6.6 | Pharmacokinetic | No |
| E.6.7 | Pharmacodynamic | No |
| E.6.8 | Bioequivalence | No |
| E.6.9 | Dose response | No |
| E.6.10 | Pharmacogenetic | No |
| E.6.11 | Pharmacogenomic | No |
| E.6.12 | Pharmacoeconomic | No |
| E.6.13 | Others | No |
| E.7 | Trial type and phase |
| E.7.1 | Human pharmacology (Phase I) | No |
| E.7.1.1 | First administration to humans | No |
| E.7.1.2 | Bioequivalence study | No |
| E.7.1.3 | Other | No |
| E.7.1.3.1 | Other trial type description | |
| E.7.2 | Therapeutic exploratory (Phase II) | No |
| E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
| E.7.4 | Therapeutic use (Phase IV) | No |
| E.8 Design of the trial |
| E.8.1 | Controlled | Yes |
| E.8.1.1 | Randomised | Yes |
| E.8.1.2 | Open | No |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | Yes |
| E.8.1.5 | Parallel group | No |
| E.8.1.6 | Cross over | Yes |
| E.8.1.7 | Other | No |
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | No |
| E.8.2.2 | Placebo | Yes |
| E.8.2.3 | Other | No |
| E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
| E.8.4 | The trial involves multiple sites in the Member State concerned | No |
| E.8.5 | The trial involves multiple Member States | No |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.1 | Trial being conducted both within and outside the EEA | No |
| E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
| E.8.7 | Trial has a data monitoring committee | Yes |
| E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | 0 |
| E.8.9.1 | In the Member State concerned months | 8 |
| E.8.9.1 | In the Member State concerned days | 0 |
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